UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060645 |
|---|---|
| Receipt number | R000069358 |
| Scientific Title | Study on the amount of activity, ADL, hematological findings, radiological findings and body composition of patients with lumber spinal canal stenosis |
| Date of disclosure of the study information | 2026/02/13 |
| Last modified on | 2026/02/10 16:38:00 |
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Basic information
Public title
Study on the amount of activity, ADL, hematological findings, radiological findings and body composition of patients with lumber spinal canal stenosis
Acronym
L-ACT study (Lumbar stenosis Activity study)
Scientific Title
Study on the amount of activity, ADL, hematological findings, radiological findings and body composition of patients with lumber spinal canal stenosis
Scientific Title:Acronym
L-ACT study (Lumbar stenosis Activity study)
Region
| Japan |
Condition
Condition
lumber spinal canal stenosis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify changes in physical activity levels and activities of daily living (ADL) before and after surgery in patients with lumbar spinal canal stenosis, and to identify prognostic factors associated with these changes.
Basic objectives2
Others
Basic objectives -Others
prognostic factors
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Metabolic equivalents (Mets)
Key secondary outcomes
Physical activity measures other than METs, obtained from activity trackers (e.g., pedometers, smartphones, or smartwatches), including step counts and overall physical activity levels, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ), 25-question Geriatric Locomotive Function Scale (Locomo-25), Falls Efficacy Scale-International (FES-I), Elderly Status Assessment Set (E-SAS), Short Physical Performance Battery (SPPB), Weight Bearing Index, Handgrip strength, Barthel Index
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who underwent surgery for lumbar spinal canal stenosis or Lumbar spondylolisthesis at our hospital
2)Patients aged 65 years or older
3)Patients who received rehabilitation treatment at our hospital
Key exclusion criteria
1)Patients for whom the outcome measures could not be assessed
2)Patients who declined participation in this study
3)Patients with a history of other spinal surgery
4)Patients who underwent other orthopedic surgery during the follow-up period
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Masachika |
| Middle name | |
| Last name | Niimi |
Organization
Nihon University School of Medicine
Division name
Department of rehabilitation medicine
Zip code
1738610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL
08015547517
nakao.wataru@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Nukii |
Organization
Nihon University School of Medicine
Division name
Department of rehabilitation medicine
Zip code
1738610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL
+81-3-3972-8123
Homepage URL
nakao.wataru@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
Tel
+81-3-3972-8123
med.rinsyokenkyu@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study examines the associations between physical activity, activities of daily living (ADL), and various clinical indicators in patients with lumbar spinal canal stenosis.
Management information
Registered date
| 2026 | Year | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069358
